In re application of: Ramstack e t a/.
`Appl. No.: 09/577,875
`Filed: .. May 25, 2000
`For: Preparation of Injectable
`Suspensions Having Improved
`Injectability
`
`Art Unit: 1615
`Examiner: R. Bennett
`Atty. Docket:. 00166.0073.USOO
`
`Decl~ration of Mark A. Tracy, Pb.D.
`Under 37 C.F.R. § 1.132
`
`Conunissiorier for Patents
`Washington~ D.C. 20231
`
`I, Mark A. Tracy, Ph.D., hereby declare and state as follows.
`
`1.
`
`I have a B.S. degree in Chemical Engineering, an M.S. degree in Chemical
`
`Engineering, and a Ph.~. degree in Physical Chemistry. I have over fifteen years experience in
`
`. qhemical engineering, chemistry, and controlled drug delivery technology. I am currently
`
`employed by Alkermes, Inc. ("Alkermes") as a Director of Formulation Development. I have
`
`1
`
`· been employed by Alkermes since July 1992. A copy of my curriculum vitae is attached.
`
`2.
`
`· The above-captioned U.S. Patent Application No. 09/577,875 ('4fue '875
`
`application") is owned by Alkermes Controlled Therapeutics Inc. l, a subsidiary of Alkennes. I
`
`have read and understood the '875 application. I am familiar with the technology ofthe ·
`
`· invention disclosed in the '875 application through my ed~cation and my work at Alkennes.
`
`3.
`
`I have read and understood U.S. Patent No." 5,656,299 to Kino eta/. ("the Kino
`
`patent"). lbe Kino:patent does not explicitly disclose the viscosity of the injection vehic1es used
`
`LUYE1018
`IPR of Patent No. 6,667,061
`
`

`
`, I • •
`
`-2-
`
`A(J1.11icants: Ramstack, eta!.
`Appl. No.: 09/577,875
`
`·:,·
`
`. in the Test -ExaJnples. The Kino patent does not provide any information about injectability, or
`
`the relati~nship betwe~n injectability and viscosity of the injection vehicle.
`
`. . A.
`
`.
`Test· Examples 1, 3, and 4 of the Kino patent use physiological saline as the·
`
`.
`
`.
`
`injection ·vehicle. Based upon my knowledge and experience, the viscosity of the physiological ·.
`
`saline inje~tion vehicle· as the fluid phase of a suspensi?n containing the micr~spheres of each of
`
`·.I
`
`Test Examples 1, 3, and 4. of cle. Kino patent is approximate~y one ( 1) centipoise ( cp) at 20°C,
`
`5~
`
`Test Example 2 of the .Kino patent. uses a 0.5o/o sodiwn carboxymethyl cellulose .
`.
`.
`.
`(CMC} solutio~ isotonized with ~annitol as the injection vehicle. Ba5~d upon my knowledge·
`
`'
`
`'
`
`and experience, the CMC is the viscosity-controlling component of the injection vehicle of Test
`.
`Example 2 of the Kino patent. That CMC is the viscosity-controlling component.is exemplifi~d·
`by the two .injection vehicles discl~sed on page 10, lines 10-17 of the '875 application as ·
`
`' .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`'
`
`.
`
`..
`
`.
`
`.
`
`.
`
`(
`
`. originally filed. The Fonnula 1 i~jection vehicle described on page 10 of the '875 application.
`
`•
`
`- .
`
`l
`
`'
`
`.
`
`•
`
`. contains 1.5% CMC, and has a viscosity of approximately 27 cp at 20°C. The Formula 2·
`.
`. injection vehicle described on page 110 of the '875 application contains0.75o/o CMC, and has a
`
`.
`
`I,
`
`viscosity of approxima~ely 7 cp at 20°C. By reducing the CMC from 1.5% to 0.75~1o, the
`. ·.
`.
`viscosity dropped from 27 cp to 7 cp. Based upon my knowledge and experience, and the
`I
`.
`.
`
`.
`
`.
`
`.
`
`'
`
`.
`.
`
`.
`
`.
`
`disclosure on page. 10, lines 1.0-17 of tJ:le '875 application, the viscosity of the CM¢ injection
`
`vehicle as the fluid phase of a suspension containing the microspheres of Test Example '2 of the
`
`.. Kino patent is less than 7 cp at 20°C.
`
`6.
`
`I hereby declare that all statements made herein of my own knowledge are true
`
`and that all statements made on information and belief are believed to be true; and further that
`
`these statements were made with the knowledge that willful false statements and the like so
`
`,
`
`I
`
`LUYE1018
`IPR of Patent No. 6,667,061
`
`

`
`- 3 -
`
`Ap.t".tcants: Ramstack, et al.
`· Appl. No.: 09/577,875
`
`made ate pWlishable by fine or imprisonment, or. both~ under § _1 OOl. of Title 18 of the United
`
`Sates Code and that such willful false statements may jeopardize the validity of the above-
`
`caption~d patent application or any patent issued thereon.
`
`. (
`
`Mark A. Tracy
`
`. .
`
`·
`
`. /
`
`LUYE1018
`IPR of Patent No. 6,667,061